Intraoperative Detection of Residual Cancer in Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Registration Number: NCT03321929

Lead Sponsor: Lumicell, Inc.

Brief Summary: This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device.

In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Detailed Description: For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed after initial resection in inferred by post-operative margin assessment of the resected tissue by a pathologist.

Phase C enrollment will include approximately 5 patients per surgeon, with 2-3 surgeons per site and up to 20 sites. Subjects undergoing a lumpectomy procedure to treat primary breast cancer will be injected with a single dose of LUM015 4 ± 2 hours prior to surgery at a dose of 1.0 mg/kg. The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Patients will receive at a minimum the standard of care practices for each site. Lumicell-guided shaved cavity margins will be removed after the surgeon has attempted to remove the main specimen with grossly negative margins.

Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 234

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Collect Data to Refine and Verify the Tumor Detection Algorithm.	1 day	Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.

Secondary Outcome Measures

Name	Time	Method
Detection and Conversion of Positive Margins in Subjects After BCS SOC	1 Week	Conversion was measured as the ratio of the subjects having all the positive margins after BCS SOC converted to negatives after Lumicell Imaging guided procedure. Detection was measured as the ratio of the subjects having all or at least one positive margin after BCS SOC detected by Lumicell Imaging System. BCS: Breast-conserving surgery; SOC: Standard of Care
Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins	1 Week	Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had positive margins after SOC.
Tumor Removal Rate Within Subjects Having All Negative SOC Margins	1 Week	Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had negative margins after SOC.
Number of Patients With Reported Adverse Events	Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).	Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Tumor Removal Rate in the Whole mITT Population by SOC Margin Status	1 week	Collect data to verify the detection algorithm reported in previous studies by SOC margin status
Volume of Therapeutic Shaves Removed During Lumpectomy.	1 Week	The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well.
Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.	1 Week	The contribution of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured as percentage of the sum of the volumes of the therapeutic shaves out of the total volume removed during lumpectomy.
Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity	1 Week	Sensitivity and specificity were measured at the tissue level for the Lumicell imaging signal for the sensitivity and specificity on the residual tumor in the cavity of corresponding orientations after standard of care (SOC) of Lumpectomy. Generalized Estimating Equation (GEE) has been applied using generalized linear model having binomial link function and compound symmetry working correlation structure within each subject.

Trial Locations

Locations (16): University of South Alabama
🇺🇸
Mobile, Alabama, United States
Stanford University Medical Center
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Palo Alto, California, United States
Yale University School of Medicine
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New Haven, Connecticut, United States
Comprehensive Breast Care Center
🇺🇸
Clearwater, Florida, United States
Baptist MD Anderson Cancer Physicians
🇺🇸
Jacksonville, Florida, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Lahey Hospital and Medical Center
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Burlington, Massachusetts, United States
Beaumont Royal Oak
🇺🇸
Royal Oak, Michigan, United States
Beaumont Troy
🇺🇸
Troy, Michigan, United States
Duke University Medical Center
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Durham, North Carolina, United States
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University of South Alabama
🇺🇸Mobile, Alabama, United States